An interventional study of Transcranial Magnetic Stimulation (TMS) and Sham Stimulation in Cerebellar Ataxia, sponsored by University of Sao Paulo General Hospital. Status unknown at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-07-11.
Sponsored by University of Sao Paulo General Hospital · Not applicable, Interventional, and Treatment
Cerebellar ataxias are a group of disorders caused by cerebellar affections, for which currently no specific treatment is available. Some limited studies verified the effects of cerebellar transcranial magnetic stimulation (TMS) on ataxic symptoms, with good results. So far it is not known which patients could benefit. Our hypothesis is that cerebellar TMS could improve ataxic symptoms in some patients.
Thirty patients with cerebellar ataxia will be included in our protocol. Ataxia might be due to several aetiologies, from degenerative to genetic and vascular diseases. Patients will be submitted to a neuronavigation protocol for the precise location of the dentate nucleus contralateral to the most symptomatic side. After that, participants will be randomly assigned to 5 active or 5 placebo sessions of 1Hz TMS over the located area. After the first 5 sessions and a period of at least 4 weeks washout, patients will cross over and receive other 5 sessions, active or sham. Clinical and video evaluations will be conducted before and after active and sham cluster of sessions.
295 studies on the registry are indexed under Ataxia; 51 are open to participants now.
This study's planned enrollment of 30 is above the median of 26 across 216 interventional studies indexed under Ataxia.
Browse Ataxia studies →University of Sao Paulo General Hospital is the lead sponsor of 595 studies on the registry; 98 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
All patients will receive 5 sessions of active TMS stimulation.
Device: Transcranial Magnetic Stimulation (TMS)
All patients will receive 5 sessions of active TMS stimulation
Device: Sham Stimulation
Low frequency (1Hz) transcranial magnetic stimulation aimed to the dentate nucleus contralateral to the most symptomatic side.
The stimulation coil will be placed in the same spot as the TMS stimulation, but coil will not be attached to the TMS machine.
Percent Change From Baseline to Post Treatment on the Scale for the Assessment and Rating of Ataxia (SARA)
Assess 8 items: gait, stance, sitting, speech, dysmetria, kinetic tremor, pro- and supinations of the hand, and the heel-shin slide. Each item is scored by the physician on a 4 to 8 numerical scale based upon the amount of dysfunction observed while performing the task. The maximum possible score for the total scale is 40. Lower scores of SARA represents better task performance.
Time frame: Day 1 (baseline), day 5 (after 5th TMS session, active or sham), day 33 (new baseline after TMS wash out) and day 38 (after 10th TMS session, active or sham)
Plan to share: Undecided
This study is status unknown, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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University of Sao Paulo General Hospital